The more important question is what they're actually held to. In the case of a diagnostic test like this, the most reasonable thing is to hold them to the false

The more important question is what they're actually held to. In the case of a diagnostic test like this, the most reasonable thing is to hold them to the false negative and false positive rates that they say the product has. No real-world diagnostic test is perfect. Instead, we design the systems around the tests to accommodate the fact that they do have errors. As long as the device manufacturer is correct about their probabilities of errors, then we can incorporate them into a system that works better than what we had before. Or we can know that we cannot use them in a useful way, and just ignore it.